Lung Cancer MetastaticProphetaProNCT05706883
Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC)
An observational study of Lung Cancer Metastatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Metastatic
- What is being tested?
- Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes and Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes
- Type of treatment
- Surgery or procedure
- How many people
- 348 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical and radiological suspicion of advanced lung cancer
Who may be able to join
- Age >18 years at the time of the procedure;
- Suspected advanced, treatment naïve non-squamous NSCLC ;
- Indication to biopsy for diagnosis and/or molecular profiling;
- Written informed consent to the study participation.
Who cannot join
- Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
- Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
- Platelet count <50.000 per μL;
- Inability or unwillingness to provide a written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mutational Profile of Patients With and Without Neck and Supraclavicular Lymph Nodes Metastasis From Advanced Non-squamous Non-small-cell Lung Cancer: a Prospective Cohort Study
Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.
- Conditions
- Lung Cancer Metastatic
- Being tested
- Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes, Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle or forceps biopsy of cervical and/or supraclavicular lymph nodesProcedure or surgery
Also called Ultrasound guided biopsy
Patients with evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes suspected of being metastasis from lung cancer will be submitted to the biopsy from this location.
Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodesProcedure or surgery
Also called Ultrasound guided biopsy, Forceps biopsy during bronchoscopy, Surgical biopsy
Patients without evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes will be submitted to the biopsy considered less invasive and effective based on imaging data and clinical health status.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis Receives: Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes | |
| Control group | Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis Receives: Procedure: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of KRAS mutation
Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
Measured: 2 months
Secondary outcomes (4)
Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK
Number of participants with EGFR, ALK, ROS1, BRAF, RET, MET, NTRK mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
Measured: 2 months
Tumor proportion score of PD-L1
Number of participants with a tumor proportion score of PD-L1 < 1%; 1-50%; >50% in the two groups (patients with and without cervical/supraclavicular lymph node metastasis)
Measured: 2 months
Prevalence of cervical/supraclavicular lymph node metastasis
Number of participants with cervical/supraclavicular lymph node metastasis in the whole cohort of patients with stage IV lung cancer
Measured: 2 months
Predictors of cervical/supraclavicular lymph node metastasis
Association between the presence of cervical/supraclavicular lymph node metastasis and the following factors: age, sex, smoking habit, tumor histologic type, central vs peripheral primary tumor, enlarged and/or PET positive N2 or N3 lymph nodes in the middle mediastinum, and molecular profile.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocco Trisolini, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706883
- Sponsor's protocol ID
- 5394
- Acronym
- ProphetaPro
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutational Profile of Patients With and Without Neck and Supraclavicular Lymph Nodes Metastasis From Advanced Non-squamous Non-small-cell Lung Cancer: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05706883
- Acronym / sponsor ID
- ProphetaPro / 5394
- Conditions
- Lung Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodesPatients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis |
| Control group | – | Procedure: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodesPatients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical and radiological suspicion of advanced lung cancer
Key inclusion criteria (4 listed)
- Age >18 years at the time of the procedure;
- Suspected advanced, treatment naïve non-squamous NSCLC ;
- Indication to biopsy for diagnosis and/or molecular profiling;
- Written informed consent to the study participation.
Key exclusion criteria (4 listed)
- Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
- Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
- Platelet count <50.000 per μL;
- Inability or unwillingness to provide a written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle or forceps biopsy of cervical and/or supraclavicular lymph nodesAlso: Ultrasound guided biopsyPatients with evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes suspected of being metastasis from lung cancer will be submitted to the biopsy from this location. | Procedure or surgery | Experimental group |
| Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodesAlso: Ultrasound guided biopsy, Forceps biopsy during bronchoscopy, Surgical biopsyPatients without evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes will be submitted to the biopsy considered less invasive and effective based on imaging data and clinical health status. | Procedure or surgery | Control group |
Primary outcome
Prevalence of KRAS mutation
Time frame: 2 months
Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
4 secondary outcomes
Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK
Time frame: 2 months
Tumor proportion score of PD-L1
Time frame: 2 months
Prevalence of cervical/supraclavicular lymph node metastasis
Time frame: 2 months
Predictors of cervical/supraclavicular lymph node metastasis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco Trisolini, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Metastatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of KRAS mutation (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.